) Oversee the validation and lifecycle control of external computerized systems used by CROs or third-party service providers...
development;Conducting inspections, audits, and risk assessments to identify hazards, recommending control measures, monitoring...
bij complexe root cause analyses. Actieve deelname aan projecten met betrekking tot Incoming Control en Incoming Release. Team...
and “SOSD†(See it, Own it, Solve it, Do it) attitude within Patient Supply Quality Control. Deliver general cGMP training... levels. Support regulatory inspections/audits, providing dynamic assistance to SME's. PATIENT SUPPLY QUALITY CONTROL...
, and quality systems. Areas of expertise should include compliance, quality assurance, quality control, validation, technical...
, FDA, PIC/S, ICH) Follow up of product related: change control, failure investigation, deviations, CAPA and action plans...
, structural engineering, mechanical systems, electrical drives, and control & automation systems. You manage and steer...
of structured problem-solving methodologies (e.g., FMEA) Experience with control systems (PLC, SCADA) Flexibility for shift work...
Strong project engineering fundamentals GMP knowledge is a plus Strong plus (not mandatory): Design control Medical device... regulations Product design in MedTech Injection techniques related to MedTech Risk assessment and control strategy in MedTech...
d'implémentation de ces stratégies (Change Control, autres) – Déterminer les impacts validation sur base des release notes.... o Identifier l'approche d'implémentation de ces stratégies (Change Control, autres). o Planifier, organiser et coordonner...